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OncoMatch/Clinical Trials/NCT04801797

Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

Is NCT04801797 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute myeloid leukemia.

Phase 2RecruitingMassachusetts General HospitalNCT04801797Data as of May 2026

Treatment: Cytarabine · Idarubicin · Daunorubicin · Liposomal daunorubicin and cytarabine · Venetoclax · Azacitidine — This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: * Venetoclax and azacitidine (investigational combination) * Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: NPM1 mutation

Patients < 60 years old with NPM1-mutated AML

Excluded: FLT3 TKD, ITD

Patients with FLT3-mutated AML (TKD or ITD)

Excluded: BCR ABL

known presence of BCR-Abl alteration

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic cytotoxic chemotherapy

Exception: hydroxyurea for cytoreduction, empiric intrathecal chemotherapy during diagnostic lumbar puncture, 6-MP as noted

Must not have received systemic prior antineoplastic therapy for treatment for the newly diagnosed AML, including radiation therapy, except hydroxyurea for the purposes of cytoreduction. Empiric intrathecal chemotherapy during a diagnostic lumbar puncture is allowed, as long as CNS disease is not suspected.

Cannot have received: hypomethylating therapy (azacitidine, decitabine)

Patients treated with prior hypomethylating therapy (such as azacitidine or decitabine)

Cannot have received: bone marrow transplantation

Prior bone marrow transplantation for a myeloid malignancy

Lab requirements

Kidney function

creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula or measured by 24 hours urine collection)

Liver function

AST and ALT ≤ 3.0X ULN (unless secondary to leukemia, may be eligible after PI approval); total bilirubin ≤ 2.0 x ULN (unless due to Gilbert's syndrome or non-hepatic origin)

Cardiac function

Left ventricular ejection fraction > 50% as measured by echocardiogram or MUGA scan

Adequate renal function as defined by calculated creatinine clearance ≥ 30 mL/min... Adequate hepatic function... AST and ALT ≤ 3.0X ULN... total bilirubin ≤ 2.0 x ULN... Left ventricular ejection fraction > 50% as measured by echocardiogram or MUGA scan

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • Stanford Cancer Center · Palo Alto, California
  • University of California - Davis · Sacramento, California
  • Massachusetts General Hospital Cancer Center · Boston, Massachusetts
  • Beth Israel Deaconess Medical Center · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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